March 30, 2021
As of today, our Industry has not defined any approach, nor does an official regulatory agency...
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February 24, 2021
In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM....
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January 28, 2021
The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a...
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December 18, 2020
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit...
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November 23, 2020
The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all...
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November 3, 2020
When an expert statistician is paired with an experienced set of data managers, opportunities to capitalize on...
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October 28, 2020
About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO...
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October 20, 2020
In this interview with Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), we talk to him about his...
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October 14, 2020
A credible evidence base is needed to support and document the economic value of new technologies and therapeutic...
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October 13, 2020
The combination of greater access to electronic health records, bigger electronic claims datasets, and the need for...
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October 7, 2020
With the rise in digital technologies, there has been an explosion in the volume and type of data sources. We can...
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September 25, 2020
Regulators in both the United States and Europe have responded positively to the use of synthetic control arms (SCA)s...
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September 16, 2020
Synthetic control arms (SCA) are virtual trial arms that use historical claims data and observational data to simulate...
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September 10, 2020
Single arm trials are emerging as an accepted way of assessing a new treatment intervention. They establish clinical...
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August 7, 2020
Recently a biotech approached Cytel for support with a Phase 2 Study in oncology. Regulators had requested a natural...
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August 5, 2020
Cytel is conducting two pilot projects on head-to-head comparisons using real world data. These projects in oncology...
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April 27, 2020
In the first part of this two-parts blog, I speak about how the European CDISC Committee (E3C) together with CDISC...
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April 24, 2020
In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C)...
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